Jarit Hulka Uterine Tenaculum Forceps
FDA 510(k) K082349 · J. Jamner Surgical Instruments, Inc.
510(k) numberK082349
Submission
- Device name
- Jarit Hulka Uterine Tenaculum Forceps
- Applicant
- J. Jamner Surgical Instruments, Inc.
York, PA, US - Received
- August 15, 2008
- Decision date
- November 21, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HDC – Tenaculum, Uterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
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|---|---|---|---|
| K223866 | Carevix Suction Cervical StabilizerHDC · Special | Aspivix SA | 01/25/2023SE |
| K203820 | ASPIVIX v1.1 Cervical Suction TenaculumHDC · Traditional | Aspivix SA | 08/17/2021SE |
| K142204 | Bioceptive Suction Cervical RetractorHDC · Traditional | Bioceptive, Inc. | 12/19/2014SE |
| K073182 | Gyn Disposables Tenaculum 356THDC · Traditional | Gyn-Disposables, Inc. | 11/28/2007SE |
| K062563 | Femten Cervical TenaculumHDC · Traditional | Fem Suite, LLC | 05/18/2007SE |
| K060573 | Burbank TenaculumHDC · Traditional | Vascular Control Systems, Inc. | 04/21/2006SE |
| K032585 | Transvaginal Ultrasound Probe Holder SystemHDC · Special | Ron-Tech Medical , Ltd. | 01/09/2004SE |
| K030078 | Burbank Tenaculum, Model 09-0011-01HDC · Traditional | Vascular Control Systems, Inc. | 01/24/2003SE |
| K001818 | Uterine Tenaclum HookHDC · Traditional | Towne Brothers (Pvt.), Ltd. | 08/30/2000SE |
| K992071 | Transvaginal Ultrasound Probe Holder DeviceHDC · Traditional | Ron-Tech Medical , Ltd. | 08/27/1999SE |
More from Ron-Tech Medical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K944670 | Jarit Recommended Sinus InstrumentsEOB · Traditional | 02/02/1995SE |
| K944870 | Jarit Endoscopes, Models 600-600; 600-630; 600-650; and 600-680GCJ · Traditional | 11/02/1994SE |
| K941565 | Jarit Recommended Sinus InstrumentsEOB · Traditional | 05/16/1994SE |
| K932456 | Jarit Surgical InstrumentsKNF · Traditional | 04/21/1994SE |
| K933728 | Jarit Surgical Instruments: Catalog 615-330, 615-331, 615-334, 615-335, 615-338, 615-339GEI · Traditional | 02/23/1994SE |
| K931928 | Jarit Surgical InstrumentsGCJ · Traditional | 11/10/1993SE |
| K931959 | Jarit Surgical InstrumentsGEI · Traditional | 10/05/1993SE |
| K931878 | Jarit Endoscopes, 600-600; 600-630; 600-650; 680GCJ · Traditional | 08/19/1993SE |
| K771625 | Leiningeo Aortic Punch #310-395 & 397DWS · Traditional | 09/12/1977SE |
| K771624 | Cope Lung Forceps #305-218GEN · Traditional | 09/06/1977SE |
Questions and answers
When was Jarit Hulka Uterine Tenaculum Forceps cleared by the FDA?
Jarit Hulka Uterine Tenaculum Forceps (K082349) received a 510(k) decision of Substantially Equivalent on November 21, 2008, 98 days after the submission was received.
What is the product code of K082349?
The FDA product code is HDC – Tenaculum, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.4530.